The Effect of 16-week Dietary Intake of Food Supplements Containing Collagen on Dermis Density and Other Skin Parameters

Not Applicable

Completed

• Conditions: Dermis Density; Skin Texture; Wrinkles; Skin Elasticity; Dermis Thickness; Skin Hydration
• Interventions: Dietary Supplement: CP5HA; Dietary Supplement: Placebo syrup; Dietary Supplement: CP5

• Registration Number: NCT05730517
• Lead Sponsor: VIST - Faculty of Applied Sciences

Brief Summary

The aim of the randomized, double-blind, placebo-controlled, one-period effectiveness study is to compare the effects of multiple-dose 16 weeks daily dietary supplementation with 5 g collagen alone or 5 g of collagen in combination with hyaluronic acid on skin in healthy human subjects in comparison to placebo product. The main objective is to show that test products have beneficial effects on dermis density, and also on other skin parameters and to investigate differences in the effects among test products.

Detailed Description

Single centre, randomized, double-blind, placebo-controlled, one-period effectiveness study will include 84 subjects. Subjects will be divided in three groups, 28 in each. Test group 1 (TG1) will receive investigational product 1 (CP5HA, daily dose 15 mL: collagen 5 g, hyaluronic acid (HA): 30 mg, vitamin C: 80 mg), test group 2 (TG2) will receive investigational product 2 (CP5, daily dose 15 mL: collagen 5 g, vitamin C: 80 mg) and the placebo group (PG) will receive placebo product without those active ingredients (15 mL: 0 g collagen, 0 g HA, 0 g vitamin C). Participants will test continuous administration of placebo or investigational products for 16 weeks in order to demonstrate and assess multiple-dose effects.

Study Timeline

• Study First Submitted: 2023-01-31
• Study Start: 2023-02-13
• Study First Submitted QC: 2023-02-13
• Study First Posted: 2023-02-16
• Primary Completion: 2023-07-30
• Study Completion: 2023-10-10
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-08
• Last Update Posted: 2023-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 87

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test group 1 (CP5HA Group)	CP5HA	Participants will receive investigational product 1 containing collagen (5 g/ 15 mL), hyaluronic acid (30 mg/ 15 mL) and vitamin C (80 mg/ 15 mL).
Placebo group	Placebo syrup	Placebo group participants will receive placebo syrup without active ingredients. (daily dose 15 mL: collagen: 0 mg, HA: 0 mg, vitamin C: 0 mg); continous administration of placebo product for 12 weeks.
Test group 2 (CP5 Group)	CP5	Participants will receive investigational product 2 containing collagen (5 g/ 15 mL) and vitamin C (80 mg/ 15 mL).

Primary Outcome Measures

Name	Time	Method
Change of dermis density from baseline in all test groups in comparison to placebo group after 16 weeks of dietary supplementation	16 weeks	Significant change of dermis density from baseline in test groups, in comparison to placebo group after 16 weeks of dietary supplementation with study product is expected. Dermis density will be assessed through ultrasonographic dermis intensity measurement. Differences in change of dermis density between test groups under primary objective conditions will also be evaluated.

Secondary Outcome Measures

Name	Time	Method
Change of wrinkle volume from baseline in test groups, in comparison to placebo group after 16 weeks of dietary supplementation	16 weeks	Assessment of the effects of investigational product on periorbital wrinkles after 16 weeks of dietary supplementation will be done using topography measurements. Differences between test groups will also be evaluated.
Change of skin hydration from baseline in test groups, in comparison to placebo group after 16 weeks of dietary supplementation	16 weeks	Assessment of the effects of the investigational product on skin hydration after 16 weeks of dietary supplementation. Skin hydration measurements will be performed using conductance principle. Differences between test groups will also be evaluated.
Change of dermis thickness from baseline in test groups, in comparison to placebo group after 16 weeks of dietary supplementation	16 weeks	Significant change of dermis thickness from baseline in test group, in comparison to placebo group after 16 weeks of dietary supplementation with study product is expected. Dermis density will be assessed using ultrasonography. Differences between test groups will also be evaluated.
Change of skin elasticity from baseline in test groups, in comparison to placebo group after 16 weeks of dietary supplementation	16 weeks	Significant change of skin elasticity from baseline in test groups, in comparison to placebo group after 16 weeks of dietary supplementation with study products is expected. Skin elasticity will be assessed using viscoleasticity measurement (Units of Measure: MPa). Differences between test groups will also be evaluated.
Change of skin texture from baseline in test groups, in comparison to placebo group after 16 weeks of dietary supplementation	16 weeks	For assessments of skin texture topography roughness measurements (Ra, Rq) will be performed. Significant changes from baseline in test groups, in comparison to placebo group after 16 weeks of dietary supplementation is expected. Differences between test groups will also be evaluated.

Trial Locations

Locations (1)

VIST - Faculty of Applied Sciences, Institute of Cosmetics; 🇸🇮 Ljubljana, Slovenia